Urinary Tract InfectionsNCT03176394
Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)
A study testing BLASTX Gel and McKesson Jelly in people with Urinary Tract Infections, run by Next Science TM at 1 site in United States.
Trial summary
This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- BLASTX Gel and McKesson Jelly
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2017to 18 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Absence of symptomatic UTI
- Absence of upper/lower tract obstructions
- No known allergies to the study products
- Willing to comply with all study procedures and available for the duration of the study
Who cannot join
- 17 years or younger
- Symptomatic UTI
- Presence of upper/lower tract obstructions
- Known allergic reaction to the study products
- Unable to provide signed and dated informed consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
American Medical Research Institute
Celebration, Florida, 34747
About this study
Official title: Efficacy of Bladder Catheters Lubricated With a Biofilm Disruptive Gel, in Reducing Catheter-associated Bacteriuria (CAB) Compared to Standard of Care: A PILOT Clinical Trial
This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.
Read the detailed description
This is a 2-week, single-site, randomized controlled pilot study in adults requiring short-term < 14 days catheterization. Subjects will be randomized 1:1 to either the BLASTX or SOC lubricated catheters.
Urine and catheter DNA analysis will be obtained at catheter insertion, 2 to 3 days after catheterization and at 5, 7 and 14 days if catheterization was indicated for either duration.
Informed consent discussion will be completed, ICF will be signed, prior to any study procedures.
Subjects will be included only if all of the inclusion criteria and none of the exclusion criteria have been met.
After randomization, subjects will be followed, urine samples will be collected at each scheduled visit and the catheters will be collected upon removal.
- Conditions
- Urinary Tract Infections
- Being tested
- BLASTX Gel, McKesson Jelly
- Keywords
- Foley, UTI, Biofilm, DNA
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLASTX GelDevice
Foley Catheter lubricated with BLASTX Gel
McKesson JellyDevice
Foley Catheter lubricated with McKesson Jelly
| Study group | Role | What they receive |
|---|---|---|
| BLASTX Lubricated Catheter | Experimental | Subjects for which catheterization is prescribed will be catheterized with a Foley lubricated with BLASTX. This gel lubricates with the same viscosity as McKesson Jelly and has a biofilm disruptive active ingredient. Receives: Device: BLASTX Gel |
| McKesson Jelly Lubricated Catheter | Placebo comparator | Subjects for which catheterization is prescribed will be catheterized with a Foley lubricated with McKesson Jelly. This jelly lubricates with the same viscosity as BLASTX but has no biofilm disruptive active ingredient. Receives: Device: McKesson Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine microorganisms DNA analysis
Change in microorganisms in the test group compared to the control group.
Measured: Up to 14 days
Catheter microorganisms DNA analysis
Change in microorganisms in the test group compared to the control group.
Measured: Up to 14 days
Secondary outcomes (1)
Incidence of Urinary Tract Infections (UTIs)
Number of instances of clinically symptomatic UTI in the test versus the control group
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start24 May 2017
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Why it stopped: trouble with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Science TM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Greco, MD, Study director, Next Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176394
- Sponsor's protocol ID
- CSP-005
- Status last verified
- Nov 2023
- First submitted
- 30 May 2017
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bladder Catheters Lubricated With a Biofilm Disruptive Gel, in Reducing Catheter-associated Bacteriuria (CAB) Compared to Standard of Care: A PILOT Clinical Trial
- ClinicalTrials.gov ID
- NCT03176394
- Acronym / sponsor ID
- CSP-005
- Conditions
- Urinary Tract Infections
- Keywords
- Foley, UTI, Biofilm, DNA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: trouble with enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Next Science TMIndustry (pharma, biotech, devices)
- Study start
- 24 May 2017 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.
Detailed description
This is a 2-week, single-site, randomized controlled pilot study in adults requiring short-term < 14 days catheterization. Subjects will be randomized 1:1 to either the BLASTX or SOC lubricated catheters.
Urine and catheter DNA analysis will be obtained at catheter insertion, 2 to 3 days after catheterization and at 5, 7 and 14 days if catheterization was indicated for either duration.
Informed consent discussion will be completed, ICF will be signed, prior to any study procedures.
Subjects will be included only if all of the inclusion criteria and none of the exclusion criteria have been met.
After randomization, subjects will be followed, urine samples will be collected at each scheduled visit and the catheters will be collected upon removal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLASTX Lubricated Catheter | Experimental | Device: BLASTX GelSubjects for which catheterization is prescribed will be catheterized with a Foley lubricated with BLASTX. This gel lubricates with the same viscosity as McKesson Jelly and has a biofilm disruptive active ingredient. |
| McKesson Jelly Lubricated Catheter | Placebo comparator | Device: McKesson JellySubjects for which catheterization is prescribed will be catheterized with a Foley lubricated with McKesson Jelly. This jelly lubricates with the same viscosity as BLASTX but has no biofilm disruptive active ingredient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Absence of symptomatic UTI
- Absence of upper/lower tract obstructions
- No known allergies to the study products
- Willing to comply with all study procedures and available for the duration of the study
Key exclusion criteria (5 listed)
- 17 years or younger
- Symptomatic UTI
- Presence of upper/lower tract obstructions
- Known allergic reaction to the study products
- Unable to provide signed and dated informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLASTX GelFoley Catheter lubricated with BLASTX Gel | Device | BLASTX Lubricated Catheter |
| McKesson JellyFoley Catheter lubricated with McKesson Jelly | Device | McKesson Jelly Lubricated Catheter |
Primary outcome
Urine microorganisms DNA analysis
Time frame: Up to 14 days
Change in microorganisms in the test group compared to the control group.
Catheter microorganisms DNA analysis
Time frame: Up to 14 days
Change in microorganisms in the test group compared to the control group.
1 secondary outcome
Incidence of Urinary Tract Infections (UTIs)
Time frame: 14 days
Results and safety
The study was stopped early (reason given: trouble with enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Greco, MD study director
Next Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLASTX Gel and McKesson Jelly in people with Urinary Tract Infections, run by Next Science TM at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: trouble with enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine microorganisms DNA analysis (time frame: Up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.